Clinical Trials for CFS

Sasha

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That's interesting, Andrew - someone asked a while ago whether we shouldn't have a list on Phoenix Rising of what trials were recruiting, because trials find it hard to get ME/CFS patients and yet here on the board, loads of patients would love to volunteer if only they knew about studies!

For example, there is an Ampligen study in the list in your second link that is listed as actively recruiting, with the principal investigators being Drs Petersen, Bateman and Lapp (what a team!) sponsored by Hemispherx. I find it a bit confusing about where it's actually located - I can't tell if it's Charlotte in North Carolina or somewhere in Pennsylvania (PA?). I would have thought lots of people would like to get recruited into that if they knew about it.

I think this deserves an article by Cort or someone, and a sticky list of actively recruiting trials.
 

TheMoonIsBlue

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Hi, Sasha

Actually I believe the Ampligen "study" has been going on for years. But the thing is, it is cost recovery- meaning the patient has to pay for the cost of the medication (about $25,000 US dollars I believe). So it's not a regular drug study in that respect- bascially you can just enroll to receive Ampligen if you meet certain criteria, but it isn't free. What it says is:
"Detailed Description:
An Open-Label Study of Poly I: Poly C12U (Ampligen) in Patients with Severely Debilitating Chronic Fatigue Syndrome (CFS)/Myalgic Encephalomyelitis (ME). The FDA approved the study for cost recovery. Patients enrolled in the study are responsible for costs related to the therapy, e.g., drug cost, infusion cost, cost of supplies, diagnostic and other laboratory testing."

If it was free I'm sure the study would be filled with applicants within 1 hour of being posted online LOL.

The Rituximab study is only in Norway it looks like?

Other than that there doesn't seem to be much happening but the same studies I've been checking into for the past two years.
 

Sasha

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Hi, Sasha

Actually I believe the Ampligen "open enrollment study" has been going on for years. But the thing is, it is cost recovery- meaning the patients has the pay for the cost of the medication (about $25,000 US dollars I believe). So it's not a regular drug study in that respect- bascially you can just enroll to receive Ampligen if you meet certain criteria, but it isn't free. I believe other people have received Ampligen at other locations/hospitals throughout the years but I don't know what is going on now.

If it was free I'm sure the study would be filled with patients within 1 hour of being posted online LOL.
Yikes, I've never heard of such a study! I've only heard of studies where the drugs are provided free to patients.
 

Andrew

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Actually, there has been more than one Ampligen study, and all studies did not require patients to pay. So if you are interested in an upcoming study, find out the details.
 

TheMoonIsBlue

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Hmmm.....I've been watching for years, and I don't see any new upcoming studies so far with Ampligen...just the same cost recovery that has been going on for years and years. It still says: "An Open-Label Study of Poly I: Poly C12U (Ampligen) in Patients with Severely Debilitating Chronic Fatigue Syndrome (CFS)/Myalgic Encephalomyelitis (ME). The FDA approved the study for cost recovery. Patients enrolled in the study are responsible for costs related to the therapy, e.g., drug cost, infusion cost, cost of supplies, diagnostic and other laboratory testing."

BUT, who knows what is going on with trying to get Ampligen finally FDA approved so maybe (probably?) there will be additional studies so they have more safety data which is what I think the FDA wanted. Hopefully the medication will be free then. I would also think it is likely for there to be an Ampligen trial/study on XMRV+ patients, someday.
 

Andrew

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thanks for the clarification. One thing to keep in mind with any of these studies is what the study will require. Remember, you might get the placebo, and you might be asked to get on a treadmill.
 

TheMoonIsBlue

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Ugh, I think I'd collapse if I even had to do a brisk walk for 2 minutes on a treadmill. And if the trials are only in certain locations, I (and many others) couldn't, or wouldn't, possibly move and uproot their life just to possibly get a placebo. If I lived 15 minutes away that would be different. I know thats how trials work.......If there are more trials, probably established patients of certain doctors will be able to get in first. Wish I lived near one of the "big name" ME/CFS docs.
 

*GG*

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thanks for the clarification. One thing to keep in mind with any of these studies is what the study will require. Remember, you might get the placebo, and you might be asked to get on a treadmill.
Well if getting on a treadmill was part of a study, for the really sickly of us, then I would not even bother, I think from that you could tell that they do not know what they are doing!

I did the Staci Stevens protocol with biking recently, it did not kill me as much as I thought it might, a very good thing! But it did show that I am disabled!